By Josh White
Date: Tuesday 21 Feb 2023
LONDON (ShareCast) - (Sharecast News) - Immunotherapy developer Scancell announced the completion of the monotherapy dose-finding arm of the phase 1 and 2 'ModiFY' clinical trial on Tuesday.
The AIM-traded company described the trial as a first-in-human, multicentre study investigating the safety and efficacy of the 'Modi-1' cancer vaccine in treating four different types of cancer.
According to the firm, the data collected from patients receiving the vaccine as a monotherapy was safe and well-tolerated, showing encouraging early efficacy in treating hard-to-treat cancers, such as high-grade serous ovarian carcinoma (HGSOC), triple-negative breast cancer (TNBC), and head and neck cancer.
The trial had enrolled 23 patients to date, all of whom experienced skin reactions at the injection site, indicating a T-cell response.
It also showed one confirmed partial response and seven patients with stable disease, despite having progressive disease prior to enrolling in the study.
As no dose-limiting toxicities were observed in the dose escalation cohorts, patients were continuing to be enrolled in both the ongoing monotherapy expansion cohorts and the CPI combination-dose escalation cohorts through the first half of the year.
Scancell described ModiFY as a phase 1 and 2 basket trial, investigating the use of Modi-1 - the first candidate from its 'Moditope' platform - to treat four different types of cancer; HGSOC, TNBC, head and neck squamous cell carcinoma (SCCHN), and renal cell carcinoma (RCC).
The trial was aiming to recruit up to 138 cancer patients who would either be treated with Modi-1 alone, or in combination with standard-of-care checkpoint inhibitor (CPI) therapy.
Surgical candidates with SCCHN would be randomised to receive either Modi-1 alone, or Modi-1 with pembrolizumab, sold under the 'Keytruda' brand.
"We are highly encouraged with the early efficacy data we have achieved in the ModiFY clinical trial, and safety profile to date with patients receiving Modi-1," said chief executive officer Lindy Durrant.
"These results allow us to proceed with the monotherapy expansion cohorts and into the cohorts in combination with checkpoint inhibitors as planned."
At 1150 GMT, shares in Scancell Holdings were up 10.72% at 19.93p.
Reporting by Josh White for Sharecast.com.
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